MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD

Model Number	RBY2C2860-B
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00919.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hepatic artery using ruby coils and a non-penumbra microcatheter.During the procedure, while advancing and attempting to manipulate two ruby coils, the physician experienced resistance in the microcatheter, and the pusher assemblies of the ruby coils became kinked.Therefore, the ruby coils were removed, and the microcatheter was repositioned.The procedure was completed using twelve new ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil confirmed a kinked pusher assembly.If the device is advanced against resistance during use, damage such as this may occur.During functional testing, the ruby coil was able to advance through a demonstration lantern with resistance due to the kinks in the pusher assembly.The resistance experienced during the procedure could not be determined.Further evaluation of the device revealed an additional pusher assembly kink.This damage was likely incidental to the complaint.Evaluation of the returned ruby coil revealed an undamaged and a functional device.During functional testing, the ruby coil was able to be advanced through a demonstration lantern without issue.The reported complaint could not be confirmed.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2021-00919.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11761675
• Report Number: 3005168196-2021-00918
• Device Sequence Number: 4545166
• Product Code: HCG
• UDI-Device Identifier: 00814548019314
• UDI-Public: 00814548019314
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY2C2860-B
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F102325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005